MedTrace Logo

Relative Bioavailability Of Palbociclib (PD-0332991) Under Fed And Fasted Conditions

NCT02041273 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2014-03-17

No results posted yet for this study

Summary

A relative bioavailability study of commercial palbociclib free base hard capsules to the isethionate salt palbociclib capsules ( used in Phase 1 and 2 studies) under different fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

palbociclib isethionate (phase 1 and 2 studies)

125 mg palbociclib isethionate salt under overnight fasting conditions

DRUG

palbociclib isethionate (phase 1 and 2 studies)

125 mg palbociclib isethionate salt under minimal fasting conditions (1 hr before palbociclib administration and 2 hrs post dose)

DRUG

palbociclib commercial free base capsule

125 mg palbociclib commercial free base capsule under fed conditions ( moderate fat meal)

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02041273 on ClinicalTrials.gov